Oncology/Hematology

FDA: Nipple Test No Substitute for Mammogram

A nipple aspirate test shouldn't take the place of mammography or otherwise be used on its own to screen for breast disease, the FDA warned.

"The FDA is not aware of any valid scientific data to show that a nipple aspirate test by itself is an effective screening tool for any medical condition including the early detection of breast cancer or other breast disease," the alert cautioned.

Manufactures have promoted these tests of fluid -- extracted with a pump rather than invasive sample collection -- as a stand-alone evaluation to screen and diagnose breast cancer, claiming they detect pre-cancerous abnormalities and diagnose breast cancer before mammography with just a sample of a few cells, the FDA said.

The alert, which included the National Association of Attorneys General in its stated audience, noted action taken against Atossa Genetics for inappropriate claims about its ForeCYTE Breast Health Test and the Mammary Aspiration Specimen Cytology Test.

Those tests were voluntarily pulled from the market in October with a class I recall, “which means that the product is dangerous or defective and has a reasonable chance of causing serious health problems or death,” the alert pointed out.

The only test mentioned in the alert still on the market was Halo Healthcare’s HALO Breast Pap Test.

The FDA said it will be keeping its eye on this and any other nipple aspriate test manufacturers with continued monitoring of promotional activity.

Halo Healthcare's Website calls its nipple aspirate fluid test an "early warning system" to show abnormal cells "years before they might turn into a cancerous lesion" and grow into tumors large enough to be seen on a mammogram.

A disclaimer cautions that HALO is FDA approved for the collection of nipple aspirate fluid for cytological evaluation but is not a diagnostic test and won't replace the need to undergo other clinical breast screening, like mammography.

Halo Healthcare has not had any direct contact with regulators on the matter other than regular reviews of labeling and materials, which haven’t led to citation for any violations, a company spokesperson told MedPage Today.

However, the FDA noted that it, along with the CDC, National Cancer Institute, American Cancer Society and other organizations, “agree that mammography is the most effective method for detecting breast cancer in its earliest, most treatable stages.”

The latest National Comprehensive Cancer Network guidelines specifically state that as clinical utility of nipple aspiration is still being evaluated, it should not be used as a breast cancer screening technique.

The FDA expressed concern that women and their physicians might believe the hype around such tests and skip mammograms, biopsy, or imaging.

Alternatively, "False positive results may lead to needless patient anxiety, along with unnecessary additional testing and treatment," it added.

"There was hope a number a years ago that you might be able to wash cells out of the milk ducts and find cancer that way," commented Daniel Kopans, MD, director of breast imaging at Massachusetts General Hospital.

"Those of us in the field were skeptical, and it turns out our skepticism was correct."

Donald Berry, PhD, a biostatistician at the University of Texas MD Anderson Cancer Center who serves on the National Cancer Institute’s screening and prevention PDQ editorial board, did see a possible role for the test but only with appropriate expectations.

“It’s not a replacement for mammography,” he agreed in an interview with MedPage Today at the San Antonio Breast Cancer Symposium, which was underway when the alert went out.

A finding of abnormal cells in the aspirate fluid raises the level of risk and might contribute to decisions about mammography for younger women, he suggested.

“With the right kind of counseling it’s appropriate, but it’s not always possible to get the right kinds of counseling,” he said. “It’s a dicey issue to be assessing somebody’s risk for two reasons: You don’t know what you’re going to do if somebody’s risk comes out one way or the other. And the other is what is it doing to the woman in terms of her quality of life and concern.”

UPDATE: This article, originally published Dec. 12, 2013 at 5:23 p.m., was updated with new material (Dec. 13, 2013 at 4:20 p.m.).

Crystal Phend joined MedPage Today in 2006 after roaming conference halls for publications including The Medical Post, Oncology Times, Doctor's Guide, and the journal IDrugs. When not covering medical meetings, she writes from Silicon Valley, just south of the San Francisco fog.

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